Z-0122-2011

in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with...

Name: Z-0122-2011 in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with...
Creator: Bio-Rad Laboratories Inc
Published: 2010-07-26
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2010-07-26 / Terminated / root cause: design

FDA source

Bio-Rad Laboratories Inc began a recall of in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer... on 2010-07-26. The reason FDA records is "Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0122-2011
Status: Terminated
Initiated: 2010-07-26
Posted: 2010-10-22
Terminated: 2011-10-25
Recalling firm: Bio-Rad Laboratories Inc.
Product: in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK The in2it (I) and (II) is an affinity chromatography method and is intended for the in-vitro quantitative determination of A1c in capillary blood taken from a finger prick. The test is indicated for monitoring the time averaged blood Glucose levels of known diabetics, for professional use as an indicator of overall glycemic control. The in2it (I) assay is intended for use in a physicians/doctors' office, the in2it (II) is intended for home use. The in2it Self Test system in intended for testing blood taken from a fingerstick. The test system is for self testing and for in-vitro diagnostic use only (not to be swallowed). The system shows how good glucose control has been over a two to three month period. The test system is the same as the test that has been CE marked for use in a clinical laboratory. The instructions for use have been changed with suggestions from people with diabetes. A patient study was conducted where untrained users ran their own blood tests and produced results which were as accurate as results obtained by trained users.
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.
Root cause tag: design
FDA root cause: Device Design
Action: BIO-RAD Laboratories Deeside Ltd., sent an URGENT: MEDICAL DEVICE CORRECTION letter, dated July 26, 2010, to their subsidiaries and to all customers identifying the product, the problem, and the action to be taken. Subsidiaries were to ensure that all customers received the letter with the Customer Medical Device Correction Response Form and collect the completed form from every customer. Once forms were received from all customers they were to be faxed to BIO-RAD Deeside Regulatory Affairs at +44 (0) 1244833401. Customers were instructed to run a test and visually inspect the test cartridge to detect any residual clear liquid. If the cartridge did not run properly the test was to be rejected. Customers were to run Quality Control test with each new shipment of test cartridges. Patient's results were not to be reported if the QC failed. Customers were to complete the CUSTOMER MEDICAL DEVICE CORRECTION RESPONSE FORM and fax it to the number provided on the form. For questions customers were to contact their regional BIO-RAD office.
Quantity in commerce: 90703
Distribution: Product was distributed to Bio-Rad's US subsidiary, along with 18 other distribution subsidiaries outside the US. These distributed further to other consignees. POroduct was distributed to Mexico, Korea, Singapore, Italy, South Africa, India, Australia, Spain, Greece, France, Thailand, Germany, New Zealand, China, Hong Kong, Portugal, Czech Republic, United Kingdom, Canada, Russia, Netherlands, Taiwan, Austria, Denmark, Israel, Finland and Belgium as well as to other African and Latin American countries.
Product codes and lots: Catalog numbers 281-0001EX, 281-0001, and 281-0001ST, all product manufactured sinc 2007-09-20.

Product code LCP

K041635Class IIG5 I Hba1c Test, G5 II Hba1c TestProvalis Diagnostics , Ltd. / cleared 2004-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)